The FDA’s revised Medical Food guidance turned heads last week when the agency declared that certain diseases related to nutrient deficiencies were off limits to medical foods. We previously reported on that draft guidance document here. By eliminating an entire class of diseases from the ambit of medical foods, the FDA left many existing products in limbo. So where to go from here?
The draft guidance has us revisiting a seldom-discussed dietary supplement labeling exception for “classical nutrient deficiency disease” claims. Such diseases (e.g., scurvy, pellagra) “that result from essential nutrient deficiencies (e.g., deficiencies of vitamin C, niacin) are typically caused by inadequate intake (e.g., famine, significant calorie restriction, eating disorders, alcoholism, diet practices/fad diets).” See FDA Medical Foods Guidance at Section II.24. In the medical foods context, FDA now explains that “[b]ecause such diseases can typically be managed through dietary modification alone, FDA generally would not consider a product labeled and marketed for these diseases to meet the regulatory criteria for a medical food.” Id. FDA’s admission is significant because it now claims that certain “diseases” can be managed or treated through dietary changes alone, including the use of dietary supplements.
For borderline medical foods the answer might be found in the nutrient deficiency exception in 21 U.S.C. § 343(r)(6). A disease or health condition caused by a nutrient deficiency should be remedied by correcting that deficiency. If FDA will not allow medical foods to address those conditions because changes in diet can remedy the deficiency, then surely dietary supplements should be allowed to advertise the benefits of certain products in correcting deficiencies. After all, FDA just told us that these “diseases” can be managed by changes to dietary intake. Many medical food products can theoretically be reformulated or relabeled as dietary supplements without a significant interruption in sales.
So can dietary supplement products claim to manage or “treat” diseases that are directly caused by nutritional deficiencies when medical food counterparts cannot? FDA’s regulations suggest that possibility.
FDA frequently acts against dietary supplement products making therapeutic claims on grounds that those products are actually “unapproved new drugs.” Section 101.93 governs permissible structure/function claims for dietary supplements and prevents so-called “disease” claims. But Section 101.93(g)(1) expressly excludes certain ailments from the definition of “disease.” The regulation defines “disease” as “damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition.” (emphasis added). In other words, “essential nutrient deficiencies” are not considered “diseases” for purposes of the dietary supplement claims regulations. And if those health conditions are not “diseases,” then FDA’s campaign against unapproved “disease” language stalls.
If that sounds too good to be true it’s probably because FDA would not expand the “classical nutrient deficiency disease” exception to include any more than the most established deficiency diseases. The exemption may not be as broad as Section 101.93(g)(1) suggests. FDA would say that not all essential nutrient deficiencies qualify. The enabling statute (21 U.S.C. § 343(r)(6)) and 21 CFR 101.93(g)(2) both limit the exception to “classical nutrient deficiency diseases.” (emphasis added). We see that same language in the FDA’s medical food guidance. The meaning of “classical” in this context is unstated and ambiguous, giving FDA discretion to interpret the word narrowly. The FDA could therefore determine that the identified deficiency was not a “classical” deficiency subject to the exemption. Moreover, many ailments can be attributed to a deficiency or lack of nutrition, at least in part. Just as FDA sought to prevent medical foods from expanding into drug territory, so too would FDA curtail dietary supplements claims. Companies seeking to rely on the Section 343(r)(6) exemption would, at minimum, need to prove through credible science that the nutrient deficiency is the exclusive cause of a disease in order to assert the exemption. Although FDA enforcement in this area is limited, we might expect the agency to apply the health claim standard and require at least significant scientific agreement (SSA) showing that a disease is caused solely by the nutrient deficiency. That alone raises substantial questions, including whether a qualified claims regime could exist for nutrient deficiency “treatment” claims under Section 343(r)(6). On that note, medical food companies left scrambling after FDA’s draft guidance should also consider whether dietary supplement health claims or qualified health claims could provide patients with critical information outside of the medical food context.
Those points notwithstanding, by narrowing the medical food category, the FDA has at least reinvigorated the Section 343(r)(6) discussion. Congress’s plain intent was to provide consumers information concerning the relationship of dietary supplements and nutrient deficiency states. Forcing companies to seek drug approval for vitamin C in the treatment of scurvy would be absurd when consumers could simply be told that eating oranges cures the condition. As medicine and technology evolve and provide greater insight into disease pathologies, the Section 343(r)(6) exemption, and the purpose motivating that clause, will have greater significance. Scientific research may not operate under the FDA’s rigid structures. We need a system that bridges technologies to provide patients the best possible care. That might include treatment protocols involving both FDA approved drugs and nutritional products. For instance, CMS has approved hospital ordering privileges for nutritionists, thus reinforcing the role of nutrition as a spoke in the therapeutic wheel.
So why can drug products advertise treatment benefits but dietary supplements and foods cannot similarly advertise their complementary roles in treatment or recuperation? For instance, a dietary supplement can make a structure/function claim concerning health maintenance or general well-being before sickness onsets, but FDA prohibits a dietary supplement from claiming to support traditional therapies by providing the body with essential nutrition during treatment. Or perhaps a better question, will the FDA’s system of censorship based on rigid, mutually exclusive categories (e.g., “drug,” “dietary supplement,” “medical foods”) remain practical as medicine evolves?
While I agree that FDA should police the market for egregious offenders—i.e., those who would profit from junk science—the FDA’s recent position on medical foods stems from an inflexible system designed to control and regulate medical innovation. The medical food category provides patients nutritional products that could help manage disease alongside conventional therapies. If FDA intends to foreclose that regulatory category for certain diseases, then the “classical nutrient deficiency disease” exemption in Section 343(r)(6) should be interpreted broadly to provide helpful information concerning disease management. If not through medical foods, the FDA must provide a means to disseminate that information outside the costly and burdensome drug approval process.